API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

API for the Exchange of Medicinal Product Information (APIX), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

: scenario1-07-final-decision - TTL Representation

Page standards status: Informative

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Task ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "scenario1-07-final-decision"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "3" ] ;
fhir:lastUpdated [ fhir:v "2026-04-20T09:00:00+01:00"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Task scenario1-07-final-decision</b></p><a name=\"scenario1-07-final-decision\"> </a><a name=\"hcscenario1-07-final-decision\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 3; Last updated: 2026-04-20 09:00:00+0100</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-apix-task.html\">APIX Regulatory Task</a></p></div><p><b>identifier</b>: Resource identifier/urn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189726 (use: official, )</p><p><b>groupIdentifier</b>: <code>http://example.org/european-med-agency/work-flow-group-id</code>/urn:uuid:workflow-group-id-12345 (use: official, )</p><p><b>status</b>: Completed</p><p><b>businessStatus</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status approved}\">Approved</span></p><p><b>intent</b>: proposal</p><p><b>priority</b>: Routine</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code variation-type-ib}\">Type IB Variation</span></p><p><b>authoredOn</b>: 2025-11-15 09:00:00+0100</p><p><b>lastModified</b>: 2026-04-20 09:00:00+0100</p><p><b>requester</b>: <a href=\"Organization-org-synthpharma-ag.html\">SynthPharma AG</a></p><p><b>owner</b>: <a href=\"Organization-org-ema-srm-hmed.html\">European Medicines Agency</a></p><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.0}\">Cover Letter</span></p><p><b>value</b>: <a href=\"DocumentReference-doc1.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Cover Letter; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:\">Application Form</span></p><p><b>value</b>: <a href=\"DocumentReference-doc2.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Application Form; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.1}\">SPC, Labelling and Package Leaflet</span></p><p><b>value</b>: <a href=\"DocumentReference-doc3.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = SPC, Labelling and Package Leaflet; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.1}\">SPC, Labelling and Package Leaflet</span></p><p><b>value</b>: <a href=\"DocumentReference-doc4.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = SPC, Labelling and Package Leaflet; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.2}\">Mock-ups</span></p><p><b>value</b>: <a href=\"DocumentReference-doc5.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Mock-ups</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.P.8.1}\">Stability Summary and Conclusion</span></p><p><b>value</b>: <a href=\"DocumentReference-doc6.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Summary and Conclusion; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.P.8.3}\">Stability Data</span></p><p><b>value</b>: <a href=\"DocumentReference-doc7.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Data; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.S.7}\">Stability (Drug Substance)</span></p><p><b>value</b>: <a href=\"DocumentReference-doc8.html\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability (Drug Substance); category = Module 3</a></p></blockquote><blockquote><p><b>output</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type cover-letter}\">Cover Letter</span></p><p><b>value</b>: <a href=\"DocumentReference-docref-approval-letter.html\">Approval Letter</a></p></blockquote><blockquote><p><b>output</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type cover-letter}\">Cover Letter</span></p><p><b>value</b>: <a href=\"DocumentReference-docref-assessment-report.html\">Final Assessment Report</a></p></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203>         ] ;
fhir:code [ fhir:v "RI" ] ;
fhir:display [ fhir:v "Resource identifier" ]       ] )     ] ;
fhir:system [
fhir:v "http://example.org/european-med-agency/task-id"^^xsd:anyURI ;
fhir:l <http://example.org/european-med-agency/task-id>     ] ;
fhir:value [ fhir:v "urn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189726" ]
  ] ) ; # 
  fhir:groupIdentifier [
fhir:use [ fhir:v "official" ] ;
fhir:system [
fhir:v "http://example.org/european-med-agency/work-flow-group-id"^^xsd:anyURI ;
fhir:l <http://example.org/european-med-agency/work-flow-group-id>     ] ;
fhir:value [ fhir:v "urn:uuid:workflow-group-id-12345" ]
  ] ; # 
  fhir:status [ fhir:v "completed"] ; # 
  fhir:businessStatus [
    ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status>       ] ;
fhir:code [ fhir:v "approved" ] ;
fhir:display [ fhir:v "Approved" ]     ] )
  ] ; # 
  fhir:intent [ fhir:v "proposal"] ; # 
  fhir:priority [ fhir:v "routine"] ; # 
  fhir:code [
    ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code>       ] ;
fhir:code [ fhir:v "variation-type-ib" ] ;
fhir:display [ fhir:v "Type IB Variation" ]     ] )
  ] ; # 
  fhir:authoredOn [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime] ; # 
  fhir:lastModified [ fhir:v "2026-04-20T09:00:00+01:00"^^xsd:dateTime] ; # 
  fhir:requester [
fhir:l fhir:Organization/org-synthpharma-ag ;
fhir:reference [ fhir:v "Organization/org-synthpharma-ag" ] ;
fhir:display [ fhir:v "SynthPharma AG" ]
  ] ; # 
  fhir:owner [
fhir:l fhir:Organization/org-ema-srm-hmed ;
fhir:reference [ fhir:v "Organization/org-ema-srm-hmed" ] ;
fhir:display [ fhir:v "European Medicines Agency" ]
  ] ; # 
  fhir:input ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.0" ] ;
fhir:display [ fhir:v "Cover Letter" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc1 ;
fhir:reference [ fhir:v "DocumentReference/doc1" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:code [ fhir:v "application-form" ] ;
fhir:display [ fhir:v "Application Form" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc2 ;
fhir:reference [ fhir:v "DocumentReference/doc2" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.3.1" ] ;
fhir:display [ fhir:v "SPC, Labelling and Package Leaflet" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc3 ;
fhir:reference [ fhir:v "DocumentReference/doc3" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.3.1" ] ;
fhir:display [ fhir:v "SPC, Labelling and Package Leaflet" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc4 ;
fhir:reference [ fhir:v "DocumentReference/doc4" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.3.2" ] ;
fhir:display [ fhir:v "Mock-ups" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc5 ;
fhir:reference [ fhir:v "DocumentReference/doc5" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "3.2.P.8.1" ] ;
fhir:display [ fhir:v "Stability Summary and Conclusion" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc6 ;
fhir:reference [ fhir:v "DocumentReference/doc6" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "3.2.P.8.3" ] ;
fhir:display [ fhir:v "Stability Data" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc7 ;
fhir:reference [ fhir:v "DocumentReference/doc7" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "3.2.S.7" ] ;
fhir:display [ fhir:v "Stability (Drug Substance)" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/doc8 ;
fhir:reference [ fhir:v "DocumentReference/doc8" ]     ]
  ] ) ; # 
  fhir:output ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type>         ] ;
fhir:code [ fhir:v "cover-letter" ] ;
fhir:display [ fhir:v "Cover Letter" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/docref-approval-letter ;
fhir:reference [ fhir:v "DocumentReference/docref-approval-letter" ] ;
fhir:display [ fhir:v "Approval Letter" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type>         ] ;
fhir:code [ fhir:v "cover-letter" ] ;
fhir:display [ fhir:v "Cover Letter" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:DocumentReference/docref-assessment-report ;
fhir:reference [ fhir:v "DocumentReference/docref-assessment-report" ] ;
fhir:display [ fhir:v "Final Assessment Report" ]     ]
  ] ) . #